A nationwide shortage of EpiPen was announced in May, but the FDA is continuing to update the public with what they need to know. The cause of the shortage is being attributed to manufacturing delays. Mylan Pharmaceuticals, maker of EpiPen and its generic version, along with Impax Generics, maker of Epinephrine Injection auto-injector, both attribute the shortage to manufacturing delays.
When will EpiPen be available?
Although the FDA is reporting a shortage of EpiPen, its website does say the medications are still available. The website further clarifies that supplies will vary from pharmacy to pharmacy. Mylan, the distributor, is expediting shipments to wholesalers upon receipt from Pfizer. The FDA has not set a date for the shortage to be resolved.
Pfizer is reacting by extending expiration dates on select lots of EpiPen 0.3 Auto-Injectors, along with its authorized generic. Pfizer announced the extension after reviewing stability data related to the affected lots. In a letter to its customers, Pfizer ensures the decision was based on careful review of product stability data. That letter provides detailed information for which lots are eligible to have expiration dates extended.
The FDA says they are doing everything they can to mitigate the shortage of the products. The administration says its hopeful patients can will have access to this important medication and is working with manufacturers to increase supply.
A new generic for the EpiPen has been approved
The FDA recently approved the first generic version of the EpiPen and EpiPen Jr, which will be manufactured by Teva Pharmaceuticals.
“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, M.D.
The FDA hopes this approval will improve the access individuals with severe allergies have to life-saving treatment. The FDA hopes generic alternatives to EpiPen will allow for the cost of treatment to be lowered.